Research Roundup: Prequalification for HCV self-test, Trial for antimalarials in pregnancy, Adjuvant boosts vaccines in mice

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A team led by US Food and Drug Administration researchers last week published findings suggesting that three vaccines, already approved and stored in the Strategic National Stockpile, targeting earlier H5N1 clades that circulated in the early 2000s could provide some cross-neutralizing antibodies against the currently circulating 2.3.4.4b clade, which continues to infect dairy herds and some farm workers across the United States. Federal officials are already implementing a plan to produce 4.8 million doses of an updated vaccine targeting the current clade, with the first doses expected to be delivered this month, but, before being administered to people, the shots would still need to get regulatory approval. These new study results offer hope that the old vaccines could provide some protection if there is a need to start vaccinating humans before the updated vaccines become available.Recently published results from a Phase 2 clinical trial conducted in Sudan by the Drugs for Neglected Diseases initiative and the Institute of Endemic Diseases at the University of Khartoum found promising results for a new and improved treatment for people with post-kala-azar dermal leishmaniasis (PKDL), a serious condition that can develop after treatment for visceral leishmaniasis. The current treatment for PKDL is an injectable drug given for two to three months, which can cause life-threatening toxicity and must be administered under close supervision in a hospital. The new treatment is safer, shorter, cheaper, more effective, and more patient-friendly, only requiring patients to be admitted to the hospital for 14 days followed by an oral treatment that can be completed at home, offering hope of a new and improved tool for PDKL for affected populations, like in Sudan where nearly 20 percent of patients treated for visceral leishmaniasis will develop PKDL within six months post-treatment, the highest rate worldwide.The Sabin Vaccine Institute and the Makerere University Water Reed Project recently launched a Phase 2 clinical trial testing Sabin's vaccine against Sudan ebolavirus, which can cause deadly disease, as seen in the recent outbreak in Uganda that ended only last year. Although Sabin’s vaccine was one of three candidates chosen to be included in a trial during the outbreak, the outbreak ended before the trial could begin. The vaccine candidate, which is based on the same platform as Sabin’s Marburg vaccine candidate that is already undergoing its own Phase 2 trial, was found to be safe and elicit rapid, robust, and long-lasting immune responses in Phase 1 clinical and nonclinical studies. There is currently no approved vaccine for Sudan ebolavirus.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. The US Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority, has awarded $176 million to Moderna to support the continued development of a pandemic influenza vaccine that could be used to treat bird flu in people, as concerns about the spread of bird flu cases in dairy cows across the United States continue to rise. Moderna's bird flu vaccine candidate is in very early-stage testing and uses the same mRNA technology as its COVID-19 vaccine. The new funding could support a late-stage trial of the vaccine candidate as early as next year if early study results continue to be positive. The vaccine could also be quickly redirected to target another form of influenza if a different threat emerges.A research team has developed a test that will help measure the persistence of HIV in people affected by viral strains found predominantly in Africa, which are greatly understudied, helping to fill a major gap in HIV research. Most HIV studies have focused on the strains circulating in Western countries, predominantly by men who have sex with men affected by subtype B, with much fewer studies examining strains circulating in Africa, where women are disproportionately affected. The new laboratory test allows researchers to determine whether following antiretroviral treatment there is any intact viral DNA capable of producing new viruses if antiretroviral treatment is interrupted. The test is already being used to study long-term viral persistence in Uganda and could be a vital tool in the search for an HIV cure that could target and eliminate this intact DNA reservoir.Last week, the US National Institutes of Health (NIH) announced the launch of a Phase 1 trial testing a nasal vaccine against COVID-19, the first trial conducted by NIH’s National Institute for Allergy and Infectious Diseases as part of Project NextGen, a US government initiative designed to advance the development of next-generation COVID-19 vaccines. In preclinical nonhuman primate studies, the candidate, MPV/S-2P, elicited a strong systemic immune response, as well as mucosal immunity, which plays an important role in controlling respiratory virus replication. Next-generation vaccines, including nasal vaccines, are a key tool needed to reduce COVID-19 infections and transmission as new variants of the virus continue to emerge.